Mallinckrodt Optistar Elite 60 mL Syringe with Lateral Flow Needle, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 50 pouches per case. Sterile, The purpose of this product is the injection of contrast media by means of power injector system during a diagnostic procedure.
- Company
- Mallinckrodt Inc
- Recall Initiated
- February 10, 2012
- Posted
- February 29, 2012
- Terminated
- December 24, 2013
- Recall Number
- Z-1122-2012
- Firm Location
- Cincinnati, OH
Reason for Recall
The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised.
Distribution
Worldwide Distribution - USA including Distributed worldwide: USA including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, Puerto Rico and the countries of Canada, Australia, Belgium, Brazil, Chile, Ecuador, Guatemala, Mexico, Panama, Singapore, and Uruguay.
Lot / Code Info
Catalog #: 801801; Lot #: 0008414, 0008415, 0015042, 0015043, 0022236, 0029499, 0029500, 0036252, 0036253, 0060075, 0064356, 0067043, 0071245, 0074027, 0078240, 0081116, 0085386, 0088170, 0095186, 0099109, 0102058, 0106079, 0109044, 0113426, 0120272, 0120472, 0123066, 0134341, 0141207, 0155153, 0155154, 0162123, 0235010, 0235011, 0246196, 0246197, 0260208, 0260209, 0300141, 0300142, 0309197, 0309198, 0316143, 0316144, 0316145, 0323181, 0337129, 0337130, 1007198, 1007199, 1007200, 1007201, 1021246, 1028228, 1028229, 1028230, 1028231, 1028232, 1035285, 1035286, 1035287, 1035288, 1042122, 1042123, 1049310, 1049311, 1049312, 1049313, 1056021, 1056022, 1063219, 1063220, 1070128, 1070129, 1084125, 1084126, 1091216, 1091217, 1098211, 1098212, 1105219, 1105220, 1119061, 1119062, 1119063, 1119064, 1147187, 1147188, 1154167, 1154168, 1217151, 1224177, 1231123, 1231124, 1238134, 1252133, 1252134, 1266175, 1266176, 1273129, 1273130, 1280130, 1280131, 1287134, 1287135, 1294121, 1294122, 1301131, 1301132, 1308138, 1315138, 1315139, 1322137, 1336335, 1336336, 1343177, 9023166, 9037138, 9037139, 9044170, 9044184, 9051152, 9051153, 9058256, 9058257, 9065164, 9065165, 9065448, 9072267, 9079179, 9079180, 9093273, 9093274, 9100261, 9100262, 9114150, 9114151, 9128089, 9128090, 9156194, 9156195, 9163187, 9163188, 9176144, 9176145, 9191020, 9191021, 9219142, 9219143, 9240131, 9240132, 9247098, 9247099, 9253017, 9253018, 9275101, 9275102, 9281033, 9281034, 9295029, 9295030, 9310048, 9310049, 9317055, 9317056, 9331148, 9331149, 9334065, 9338345, 9351119, 9352231, 9357639
Root Cause
Packaging process control
Action Taken
Covidien sent an Urgent Device Recall letter dated February 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product immediately. Customers were to use the attached business response form to report the quantity of each lot that is currently in their stock. If customers did not have any of these lots in stock, they should indicate by checking the appropriate box on the business report form. When completed, customers should email the completed form to covidien2600@stericycle.com or fax to 888-257-7910. For any questions customers should call 866-761-9571.